Is Benzoyl recalled?

50 FDA recalls mention Benzoyl. The most recent are listed below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Benzoyl.

Class II · Moderate risk Terminated Mar 15, 2021

Acne Medication Benzoyl Peroxide Gel USP, 5% Net Wt 1.5 oz (42.5 g) NDC 0536-1055-56 Distributed by: Rugby Laboratories 31778…

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 0536-1055-56 D-0513-2021

Class II · Moderate risk Terminated Mar 15, 2021

BENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5.3% 100GM TOP EMOL NDC 187-0194--10; OTC; FOAMS

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. D-0444-2021

Class II · Moderate risk Terminated Oct 9, 2020

MD Complete Breakout Treatment (Benzoyl Peroxide 4.5%) 1 fl. oz. (30mL) bottles, MD Professional LLC, Minneapolis, MN

Reason GMP Deviations

Milbar Laboratories, Inc. D-0091-2021

Class II · Moderate risk Terminated Oct 9, 2020

DCL B Prox10 Anti-Blemish Wash (Benzoyl Peroxide 10%), 200 ml/6.7 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512…

Reason GMP Deviations

Milbar Laboratories, Inc. D-0084-2021

Class III · Low risk Terminated Jul 6, 2020

Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl oz.; Purifying Toner (Salicylic Acid 2.0%)…

Reason SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.

Allergan PLC D-1410-2020

Class III · Low risk Terminated Jul 6, 2020

Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, CA 92612…

Reason SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.

Allergan PLC NDC 0023-4965-02 D-1409-2020

Class II · Moderate risk Terminated Jan 16, 2020

Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 bar per carton, Distributed By: Walgreen Co., 200…

Reason Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturing).

Shandex Personal Care Manufacturing Inc. D-0822-2020

Class II · Moderate risk Terminated May 4, 2018

B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA

Reason Microbial Contamination of Non-sterile Product

Milbar Laboratories, Inc. D-0811-2018

Class III · Low risk Terminated Mar 20, 2017

CLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotion (benzoyl peroxide 5% Acne Treatment) 47mL bottle…

Reason Discoloration.

Valeant Pharmaceuticals North America LLC NDC 0187-6103-01 D-0673-2017

Class II · Moderate risk Terminated Feb 10, 2017

CLEAR 2 (Benzoyl Peroxide 2.5%, Clindamycin 1.2% ), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855)…

Reason Lack of Assurance of Sterility: There are also CGMP Deviations.

Synergy Rx D-0555-2017

Class II · Moderate risk Terminated Feb 10, 2017

CLEAR (Benzoyl Peroxide 3.75%, Clindamycin 1.2% Gel), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855)…

Reason Lack of Assurance of Sterility: There are also CGMP Deviations.

Synergy Rx D-0554-2017

Class II · Moderate risk Terminated Feb 10, 2017

CLINDAMYCIN 1%, AZELAIC ACID 10% CREAM, CLINDAMYCIN 1.2%/ TRETINOIN 0.05% GEL, CLINDAMYCIN 1.2%/ TRETINOIN 0.1% GEL…

Reason Lack of Assurance of Sterility: There are also CGMP Deviations.

Synergy Rx D-0534-2017

Class II · Moderate risk Terminated Feb 10, 2017

BENZOYL PEROXIDE 5% CLINDAMYCIN 1.2%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

Reason Lack of Assurance of Sterility: There are also CGMP Deviations.

Synergy Rx D-0531-2017

Class II · Moderate risk Terminated Feb 10, 2017

ADAPALENE 0.1%, BENZOYL PEROXIDE 2.5% GEL, ADAPELENE 0.3%, BENZOYL PEROXIDE 2,5% GEL, AZELAIC ACID 15% CREAM, AZELAIC ACID 20% IN…

Reason Lack of Assurance of Sterility: There are also CGMP Deviations.

Synergy Rx D-0530-2017

Class II · Moderate risk Terminated Dec 28, 2016

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes, Rx Only, Manufactured by Perrigo, Yeruham, Israel…

Reason Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap

L. Perrigo Company NDC 45802-736-84 D-0434-2017

Class III · Low risk Ongoing Dec 6, 2016

INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only, packaged in a box containing: 30 pads of benzolyl…

Reason Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product…

Cipher Pharmaceuticals US LLC NDC 68712-013-01 D-0237-2017

Class II · Moderate risk Terminated Jan 28, 2014

Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient…

Reason Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping

RX South LLC DBA RX3 Pharmacy D-1164-2014

Class III · Low risk Terminated Sep 20, 2013

Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%, Net Wt. 3.5 g, Rx Only, Sample - not for sale, CORIA…

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an incorrect expiration date assigned to a lot of…

Valeant Pharmaceuticals North Am NDC 13548-132-03 D-020-2014

Class II · Moderate risk Terminated May 1, 2013

CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed by OMP, Inc., Long Beach, CA 90806, Kit is comprised…

Reason cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore…

Medicis Pharmaceutical Corp D-916-2013